- Title
- The effectiveness of natalizumab vs fingolimod - A comparison of international registry studies
- Creator
- Andersen, Johanna B.; Sharmin, Sifat; Lefort, Mathilde; Koch-Henriksen, Nils; Sellebjerg, Finn; Sørensen, Per Soelberg; Hilt Christensen, Claudia C.; Rasmussen, Peter V.; Jensen, Michael B.; Frederiksen, Jette L.; Bramow, Stephan; Mathiesen, Henrik K.; Schreiber, Karen I.; Horakova, Dana; Havrdova, Eva K.; Alroughani, Read; Izquierdo, Guillermo; Eichau, Sara; Ozakbas, Serkan; Patti, Francesco; Onofrj, M; Lugaresi, A; Terzi, M; Grammond, P; Grand Maison, F; Yamout, B; Prat, A; Girard, M; Duquette, P; Boz, C; Trojano, M; McCombe, P; Slee, M; Lechner-Scott, Jenette; Turkoglu, R; Sola, P; Ferraro, D; Granella, F; Shaygannejad, V; Prevost, J; Skibina, O; Solaro, C; Karabudak, R; Wijmeersch, BV; Csepany, T; Spitaleri, D; Vucic, S; Casey, R; Debouverie, M; Edan, G; Ciron, J; Ruet, A; Sèze, JD; Maillart, E; Zephir, H; Labauge, P; Defer, G; Lebrun, C; Moreau, T; Berger, E; Clavelou, P; Pelletier, J; Stankoff, B; Gout, O; Thouvenot, E; Heinzlef, O; Al-Khedr, A; Bourre, B; Casez, O; Cabre, P; Montcuquet, A; Wahab, A; Camdessanché, JP; Marousset, A; Patry, I; Hankiewicz, K; Pottier, C; Maubeuge, N; Labeyrie, C; Nifle, C; Leray, E; Laplaud, DA; Butzkueven, H; Kalincik, T; Vukusic, S; Magyari, M
- Relation
- Multiple Sclerosis and Related Disorders Vol. 53, Issue August 2021, no. 103012
- Publisher Link
- http://dx.doi.org/10.1016/j.msard.2021.103012
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2021
- Description
- Background: Natalizumab and fingolimod were the first preparations recommended for disease breakthrough in priorly treated relapsing-remitting multiple sclerosis. Of three published head-to-head studies two showed that natalizumab is the more effective to prevent relapses and EDSS worsening. Methods: By re-analyzing original published results from MSBase, France, and Denmark using uniform methodologies, we aimed at identifying the effects of differences in methodology, in the MS-populations, and at re-evaluating the differences in effectiveness between the two drugs. We gained access to copies of the individual amended databases and pooled all data. We used uniform inclusion/exclusion criteria and statistical methods with Inverse Probability Treatment Weighting. Results: The pooled analyses comprised 968 natalizumab- and 1479 fingolimod treated patients. The on-treatment natalizumab/fingolimod relapse rate ratio was 0.77 (p=0.004). The hazard ratio (HR) for a first relapse was 0.82 (p=0.030), and the HR for sustained EDSS improvement was 1.4 (p=0.009). There were modest differences between each of the original published studies and the replication study, but the conclusions of the three original studies remained unchanged: in two of them natalizumab was more effective, but in the third there was no difference between natalizumab and fingolimod. Conclusion: The results were largely invariant to the epidemiological and statistical methods but differed between the MS populations. Generally, the advantage of natalizumab was confirmed.
- Subject
- multiple sclerosis; natalizumab; fingolimod; treatment effectiveness; head-to-head comparison
- Identifier
- http://hdl.handle.net/1959.13/1424609
- Identifier
- uon:38113
- Identifier
- ISSN:2211-0348
- Language
- eng
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